The present invention relates to a method and a device for protecting a catheter, and in particular, though not limited to a method and a device for protecting a balloon catheter during use of the catheter in a procedure, so that the catheter may be reused, and the invention also relates to a method for locating a catheter and a balloon catheter at a remote site, such as a remote site in a human or animal body with the catheters protected, so that the catheters may be reused.
Catheters are commonly used for gaining access to a remote site in a human or animal body, in order to facilitate the carrying out of a procedure or an investigation at the remote site. Access to the remote site is gained through a lumen, a vessel or a vascular system of the human or animal body, within which the remote site is located. For example, catheters are commonly used to gain access to the oesophagus, the lower oesophageal sphincter, the stomach and other parts of the digestive system of the human or animal body. Catheters for gaining access to the oesophagus, stomach and the like, typically are inserted nasally or orally into the oesophagus. Catheters are also used to gain access to remote sites in the bowel, large and small intestine, and in such cases, the catheter typically is rectally inserted. Catheters are also used to gain access to the uterus, the urinary tract and the like. Additionally, catheters are used to gain access to the vascular and cardiovascular system. All such catheters, in general, are used once and disposed of due to the difficulty in cleaning and sterilising such catheters after use, and in particular, cleaning and sterilising a lumen or lumens of such catheters which are exposed at, for example, a distal end of the catheter, such as a guide wire accommodating lumen. However, such catheters, in general, tend to be relatively expensive, and in general, balloon catheters are particularly expensive, in particular, balloon catheters which are adapted for determining the volume of a remote vessel or lumen, or for determining the transverse cross-sectional area or diameter and/or distensibility of a remote sphincter, vessel or lumen, tend to be particularly expensive. It would therefore be advantageous if such catheters could be reused.
It is, however, known to provide a protective sheath which extends over a catheter. Such a sheath is sold under the Trade Mark MANOSHIELD of Sierra Scientific Instruments. A catheter is threaded into the sheath prior to use, and on being fully inserted into the sheath, the sheathed catheter is then inserted into the appropriate lumen, vessel or vascular system of the human or animal body and directed towards a remote site at which a procedure or investigation is to be carried out. On completion of the procedure or investigation, the sheathed catheter is removed, and the sheath is then removed from the catheter. Thus, any bodily fluids or contaminants with which the sheathed catheter may have come into contact within the lumen, vessel or vascular system, and which may have adhered to the sheath are removed with the sheath as the sheath is being removed from the catheter. Thus, with the sheath removed, the catheter is clean and is ready for re-sheathing and reuse.
However, the sheath which is sold under the Trade Mark MANOSHIELD suffers from at least two problems. Firstly, the sheath is unsuitable for use with a balloon catheter, since the sheath would inhibit inflating of a balloon on the balloon catheter. Secondly, the sheath is unsuitable for use with a guide wire. For example, it is not possible to initially direct a guide wire to a remote site at which the procedure or investigation is to be carried out, and then subsequently pass the catheter along the guide wire, since the distal end of the sheath would have to be punctured to accommodate the guide wire through a guide wire accommodating lumen in the catheter. Thus bodily fluids and other bodily matter adhering to the guide wire would come into contact with the inner surface of the guide wire accommodating lumen of the catheter, thereby contaminating the catheter and thus rendering it unsuitable for reuse.
There is therefore a need for a method and a device for protecting a catheter during a procedure or investigation at a remote site in a human or animal body, so that the catheter can be reused on completion of the procedure or investigation. There is also a need for a method for facilitating use of such a protected catheter with a guide wire whereby the guide wire is initially used to access a remote site at which a procedure or investigation is to be carried out, which addresses at least some of the problems of prior art methods and devices.
The present invention is directed towards providing a method and a device for protecting a catheter, and the invention is also directed towards providing a method for locating a catheter at a remote site, for example, a remote site in a human or animal body, so that the catheter may be reused.